Solius押注FDA新设非处方UVB类别，以2995美元售卖家庭阳光

做的是什么生意

Solius Labs sells Solius Pro, a wall-mounted panel with 132 UVB LEDs whose app scans skin pigmentation and personalizes a weekly dose of under five minutes, cleared by the FDA to stimulate vitamin D production in adults 22 and older.

启动资金：Solius closed a $23M Series A led by Lauder Partners in June 2026, announced alongside the Solius Pro launch.

起因

The bet started with a measurement problem: UVB light drives vitamin D production and other biological processes, but sunlight is nearly impossible to dose safely — factors like season, latitude, skin tone and sun sensitivity make a consistent beneficial dose impractical, while phototherapy with UVB existed only in medical settings. Solius designed a home panel and algorithm to change that, then faced the harder question: no regulatory path existed for selling UVB therapy over the counter.

经过

The FDA answered by creating a new product code for the device. Solius submitted the Solius Pro UVB Light Panel as a traditional 510(k) on 2025-09-16 and received a substantially-equivalent decision on 2026-01-16, clearing it as a Class II medical device for over-the-counter marketing — stimulating vitamin D production in people 22 and older — under the new SGZ code. In an August 2025 randomized controlled trial funded by Solius, 69 participants over 21 weeks saw serum vitamin D rise by about 10 ng/mL on average with no skin damage or tanning. On 2026-06-16 the company launched Solius Pro at $2,995 with a $100-per-year membership, backed by a $23M Series A led by Lauder Partners and more than 1,000 pre-orders.

结果

Solius Pro went on sale in the US on 2026-06-16 as the first FDA-cleared over-the-counter UVB therapy device, with shipping starting in July 2026 — the company turned a regulatory category that did not exist into its launch moat.

可借鉴之处

当产品需要一个不存在的类别时，让监管者创建它才是真正的发布：新的FDA产品代码是Solius的护城河，而不是其文书工作。